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NCT03122886

Fat Emulsion in Preventing Hypersensitivity Reactions in Patients With Cancer Receiving Carboplatin or Oxaliplatin

Completed NA Results posted Last updated 17 December 2024
What this trial tests

NA trial testing Fat Emulsion in Advanced Malignant Neoplasm in 19 participants. Completed in 31 July 2019.

Timeline
14 July 2017
Primary endpoint
31 July 2019
31 July 2019

Quick facts

Lead sponsorMayo Clinic
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment19
Start date14 July 2017
Primary completion31 July 2019
Estimated completion31 July 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Advanced Malignant Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time-to-carboplatin or Oxaliplatin Acute Hypersensitivity Reaction Primary · Up to 2 years

The primary endpoint is the time to healthcare provider reported hypersensitivity reactions from either carboplatin or oxaliplatin. Kaplan Meier curves will be constructed and a log-rank test will be used to compare time-to-hypersensitivity reaction between treatment arms. Data will be censored based on last infusion with no hypersensitivity reaction with a maximum study treatment duration of 2 years per patient.

GroupValue95% CI
Group I (Fat Emulsion)4.41.4 – 4.4
Group II (Placebo)NA2.8 – NA

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 years. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Group I (Fat Emulsion)
Serious: 1/9 (11%)
Deaths: 0/9
Group II (Placebo)
Serious: 2/7 (29%)
Deaths: 0/7

Serious adverse events (4 terms)

ReactionSystemGroup I (Fat Emulsion)Group II (Placebo)
Febrile neutropeniaBlood and lymphatic system disorders
DysphagiaGastrointestinal disorders
Gen disord and admin site conds-Oth specGeneral disorders
DyspneaRespiratory, thoracic and mediastinal disorders
Other adverse events (3 terms — click to expand)

ReactionSystemGroup I (Fat Emulsion)Group II (Placebo)
Allergic reactionImmune system disorders
Alkaline phosphatase increasedInvestigations
Aspartate aminotransferase increasedInvestigations

Most-reported serious reactions: Febrile neutropenia, Dysphagia, Gen disord and admin site conds-Oth spec, Dyspnea.

Data from ClinicalTrials.gov NCT03122886 adverse events section.

Sponsor's own description

This randomized pilot trial studies how well fat emulsion works in preventing hypersensitivity reactions in patients with cancer receiving carboplatin or oxaliplatin. Giving lipids before chemotherapy may prevent some drug reactions from carboplatin or oxaliplatin.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Advanced Malignant Neoplasm

Currently open trials in the same condition.

Other Mayo Clinic trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03122886.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing